In February 2013, Chelsea received written guidance from the Director of the Office of New Drugs at the U.S. Food and Drug Administration (FDA) stating that Study 306B has the potential to serve as the basis for a resubmission of a Northera (droxidopa) New Drug Application (NDA) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). The guidance suggested that "data strongly demonstrating a short-term clinical benefit… of droxidopa in patients with NOH would be adequate for approval, with a possible requirement to verify durable clinical benefit post-approval." It further notes that any decision regarding the outcome of an FDA review, to be performed by the DCRP will be based on the strength of Study 306B and its ability to provide substantial evidence of effectiveness to support approval.

As a result of FDA's guidance, the Company intends to resubmit the Northera NDA in late second quarter 2013. Chelsea also intends to initiate a new clinical trial in the fourth quarter of 2013, given FDA guidance regarding the potential need for Chelsea to verify the durability of effect of Northera in a post-marketing study. This study would also include short-term clinical endpoints should the Agency require an additional clinical trial for the approval of Northera.

In December 2012, Chelsea reported that Study 306B demonstrated statistically significant improvements for Northera compared to placebo in dizziness/lightheadedness at week 1 (p=0.018), the primary endpoint, and increase in standing systolic blood pressure at week 1 (p=0.032), an important secondary endpoint. Treatment with Northera also resulted in a reduction in patient falls and fall-related injuries, although the results were not significant. The safety data were consistent with previous studies, and showed that Northera was well tolerated.

In November 2012, Chelsea announced positive results from a clinical study of Northera in hypotensive individuals with spinal cord injury (SCI) at the 23 rd International Symposium on the Autonomic Nervous System. These preliminary data indicated that Northera increases seated blood pressure in a dose dependent manner without worsening supine increases in blood pressure in hypotensive patients with SCI, suggesting a greater normalization of blood pressure across positional changes.

"Chelsea now has a regulatory path forward for Northera in NOH. We look forward to interacting with FDA to provide the necessary analyses for a thorough review of our resubmitted NDA and to collaborate on the design of the next clinical study," said Joseph G. Oliveto, Interim CEO of Chelsea. "As previously announced, we ended 2012 with cash and cash equivalents of approximately $28.4 million. We will continue to diligently manage our existing funds which we expect will fund operations into the third quarter of 2014, well past the currently projected Northera approval determination date."

Chelsea CEO Joe Oliveto and his team deserve a lot of credit for cleaning up some messy Northera clinical trials, scoring at the FDA advisory panel, securing the drug's approval and now delivering on the exit strategy that everyone wanted.

Wedbush believed that Chelsea Therapeutics International is an attractive acquisition or partnership target for multiple pharmaceutical companies because of the approval of NortheraThe stock price of ...